Q4 2023 Esperion Therapeutics Inc Earnings Call
Participants
Alexis Callahan; IR; Esperion Therapeutics, Inc.
Sheldon Koenig; President & CEO; Esperion Therapeutics, Inc.
Ben Halladay; CFO; Esperion Therapeutics, Inc.
Eric Warren; Chief Commercial Officer; Esperion Therapeutics, Inc.
JoAnne Foody; Chief Medical Officer; Esperion Therapeutics, Inc.
Serge Belanger; Analyst; Needham & Company LLC
Tom Shrader; Analyst; BTIG
Jason Zemansky; Analyst; BofA Global Research
Presentation
Operator
Good morning, ladies and gentlemen. Thank you for standing by and welcome to Esperion's fourth-quarter 2023 earnings conference call.(Operator Instructions) Please be advised that today's conference call may be recorded. I would now like to hand the conference over to Alexis Callahan, Head of Investor Relations at Esperion. Please go ahead, Alexis.
Thank you, operator.
Alexis Callahan
Good morning, and welcome to Esperion's fourth quarter and full year 2023 earnings conference call. With us today are Sheldon Koenig, President and CEO, and Ben holiday, CFO, and other members of the executive team will be available for Q&A following our prepared remarks, we issued a press release earlier this morning detailing the content of today's call.
A copy can be found on the Investor page of our website, together with a copy of the presentation that we will also be referencing. I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business.
These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, February 27th, 2024, and we undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast as a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions.
I'll now turn the call over to Sheldon Koenig, President and Chief Executive Officer.
Sheldon Koenig
Thank you, Alexis, and good morning, everyone. Thank you for joining us today to discuss our fourth quarter and full year results and the significant progress we continue to make. We are pleased to report another strong quarter as well as key material events in January that we believe put our company on solid footing and further position us for continued long-term success.
Starting with our quarterly performance, total revenue was $32.3 million, which represents a 72% increase year over year U.S. net revenue came in at $20.8 million, which represents a 39% increase year over year, driven by a 44% year-over-year increase in retail prescription equivalents. We believe the continued growth seen in both the US and in our global territories is a testament to the strength of our clinical data, the unmet need in the market and our teams and partners' abilities to execute listed here are several recent accomplishments worth calling out. We delivered another strong quarter that positions us for continued success in the long term and significantly transforms our capital position and investment profile. Prescription growth continued at a strong pace, and we're proud of the momentum that we sustained through the end of the year.
Additionally, we resolved our pending litigation with DSC and expanded our partnership on mutually beneficial terms. We further strengthened our balance sheet with additional capital, emphasizing our strong cash position and bringing in several new long-term biotech investors. Our label expansion approvals remain on track in both the US and Europe. We published additional important data from our CLEAR Outcomes trial, and we remain focused on preparation for our new label, expanding our commercial organization to ensure we're ready to fully capitalize on the opportunity when we receive approval next month.
At January third, we announced a settlement agreement and an amendment to our collaboration with Daiichi Sankyo Europe, which Mark the resolution of our pending litigation settlement was mutually beneficial and reflects both parties' commitment to our ongoing partnership to deliver our medications to patients worldwide and address global unmet need. Importantly, we believe the closure of this matter significantly strengthens our investment profile, reduces costs associated with the litigation and is an excellent outcome for both parties. It provides for significant near term cash payments, inventory and gross margin savings and potentially extend our European product lifecycle while generating additional potential royalty streams in the DS. territories.
The net result of all components of our agreement provides both near and long-term value. It allows us to continue focusing on running our business combining our year-end cash balance. With the $100 million settlement payment received in January and proceeds from our recent offering, we significantly strengthened our liquidity position, which enables us to invest in initiatives that support the long-term success of Esperion. With the litigation now resolved and the infusion of additional cash, we are poised for significant growth in 2020 for now let me turn to our upcoming label expansion, which we anticipate will include a new broad cardiovascular risk reduction indication, expand access to the primary prevention patient population or those at risk of an event, not just those who have already had one and they moved the stat use requirements.
These are significant changes to our current label, supported by our robust CLEAR outcomes data and are expected to drive substantial future growth. I'm pleased to share that reviews of our pending applications with the FDA and EMA are progressing extremely well. And these positive discussions remain in line with our strategic goals. We are on track with an FDA PDUFA date of March 31st, with an expected decision by the EMA on our European label, likely coming in the second quarter based on our existing label and narrow indication, our current addressable market is around 10 million patients in the U.S. upon approval of our new anticipated label our models predict an opportunity that triples to around 30 million patients.
That figure, however, does not include an additional 40 million untreated individuals who are at high risk and who are still not at their LDL-cholesterol goal. We see vast potential for our products to help millions more patients in the future, reiterating our eagerness for the FDA's anticipated approval today, I'd like to outline the five core pillars that will ensure our life-saving products, Netflix, all AndexXa that reach the appropriate patients.
One, our expanded label, our anticipated new label will reflect clear outcomes data and will also create a differentiated and expanded indication that includes high risk primary prevention patients to all new promotion, current commercial resources for Nexavar.
And next was that our focus on LDL cholesterol reduction in patients with ASCVD on maximally tolerated statins. It's still not at their LDL cholesterol goal. Based on the anticipated new label, the team has prepared a powerful suite of promotional tools that will communicate the CLEAR outcomes data across the expected new and expanded patient population.
Extensive market research has been conducted to ensure the right sequence of data will be communicated at the right time three deeper reach. I'm proud to announce that we've completed our sales force expansion and have recently deployed 60 new territory managers into the field bringing our team up to 150 representatives.
These motivated individuals, together with improved digital resources, will allow us to expand our depth and breadth to reach a target universe of 45,000 health care providers comprised of both primary care providers and specialists for patient activation. We've created a bold new consumer campaign to drive awareness and ensure appropriate patients have discussions with our health care providers about next little And next to that and five payer access and reimbursement.
Finally, we continue to align payers utilization management criteria with our anticipated label to include primary prevention and primary hyperlipidemia, while at the same time enhancing our patient service programs to support both patients and healthcare providers alike were also pleased to announce that ICE or the Institute for Clinical and Economic Review just determined that for that as a cost effective therapy, which adds support for its value proposition to payers, we believe our recent achievements and changes we've implemented set us up for long term, sustained growth. Shown here are a series of important commercial clinical regulatory and financial milestones that we expect to be achieved along the way, you'll see that this steady stream of catalysts begin to form a roadmap for long-term value growth.
We've already expanded our sales force and anticipate label expansions in both the US and Europe. With expected new global labels, we anticipate guidelines to be updated. In addition, we expect to file INDs or investigational new drug applications for our next-generation ACLY. inhibitors to lay the groundwork for growing our product pipeline beyond bempedoic acid.
Furthermore, our partners will continue launching our products in even more new territories on a regular cadence creating additional revenue streams and bolstering our growing global franchise. Longer term, the optimization of our balance sheet and partnership related cost savings should enable us to continue to enhance our capital position over time.
We also see meaningful revenue contribution stemming from the potential for a triple combination therapy in Europe, additional milestone payments from our network of partners, additional ex-US opportunities and continued growth stemming from further advancement of our preclinical pipeline. On that note, I'm excited to announce our intent to hold an R&D Day later this year to review our pipeline of next-gen ACLY inhibitors in more depth.
With that, I will now hand it over to Ben Halladay, our Chief Financial Officer, for a more detailed review of our fourth quarter performance.
Ben Halladay
Thank you, Sheldon. Earlier this morning, we issued a press release containing our financial results for the fourth quarter, which is available on the Investor page of our website. Please note that unless otherwise specified, my comments reflect results for the fourth quarter ended December 31, 2023.
As Sheldon already mentioned, we posted strong fourth quarter results and ended the year with continued momentum included in new-to-brand prescriptions. We ended the year on a strong note, which really emphasizes the point that outcomes data matters, and we're excited for that data to be incorporated into our new label next month and for what it means for patient access and our ability to actively promote the data for the first time, we again delivered another quarter of continued growth in retail prescription equivalents, which increased 44% year over year and 8% quarter over quarter and was accomplished even with our current label and promotional footprint before recently ramping up our in-house sales force weekly. Our PE. trend also reflects this momentum and touch the 12,000 RPE. mark late in the fourth quarter and new weekly highs.
Turning to growth outside the US, our partner GSC again delivered another strong quarter of sales growth in its territories. Underscoring the value our approved medicines are bringing to the patients globally. At the end of November, approximately 202,000 patients have now been treated with our therapies in Europe, representing sequential three-month growth of 28% since August. I will note that most of this growth has been generated from existing territories. That said, DSE commercially launched in three new territories during the fourth quarter. The Netherlands Slovakia and Spain and gained approval in Czech Republic as well. In addition, Daiichi Sankyo launched in Hong Kong during Q4, marking the first country in the Asia region to launch.
Turning to our full financial results for the quarter, we reported U.S. net product revenue of $20.8 million, representing an increase of 39% year over year collaboration revenue, which includes combined royalty and partner revenue was $11.5 million, an increase of 195% year over year. Finally, total revenue for the fourth quarter was $32.3 million, an increase of 72% year-over-year.
Turning to expenses, cost of goods sold for the fourth quarter was $11.5 million, an increase of 174% year over year, driven primarily by higher tablet shipments to our partners to support new country launches. R&d expense was $17.7 million, a decrease of 46% year over year, reflecting substantially lower costs following the close out of our CLEAR Outcomes trial.
SG&A expense was $45.4 million, an increase of 88% year over year, reflecting higher legal and promotional costs as well as higher headcount as we began to ramp up our in-house sales force. Of note, we incurred $13.1 million in one-time legal expenses related to our litigation resolution with DSC that are nonrecurring in nature.
Finally, cash equivalents and investment securities available for sale totaled $82.2 million as of December 31st, 2023, compared with $166.9 million on December 31st, 2022. Although that figure does not include the settlement related cash payment we received in January, nor the proceeds from our recent public offering today, we are also reiterating the 2024 expense guidance we put forth last month. For the full year 2024.
We expect R&D expense to be between $45 million and $55 million, SG&A expense to be between $180 million and $190 million and total OpEx to be between $225 million and $245 million. Although the total operating expenses are expected to come in the same level of last year. We've just shifted dollars from our R&D budget to the SG&A budget to reflect the close out of the clear Outcomes and ramping up the commercial activities to support our new and expanded label. While we have materially strengthened our balance sheet in recent weeks, we remain disciplined when it comes to expense allocation, ensuring the investments we make, including those to support our commercial launch are generating sufficient returns.
And with that, let me now hand it back over to you, Sheldon.
Thank you.
Sheldon Koenig
Then I'd like to close by reiterating that we continue to deliver on our commitments and execute on our strategic plan to achieve blockbuster status. Sales are continuing to accelerate following publication of our CLEAR outcomes data last year, and we anticipate a true inflection to occur after we receive approval of our new and expanded labels in the US and Europe later this year.
Our strategic plan also consists of an expansion of our product pipeline as we further develop our next-gen ACLY. inhibitors. We will further expand on our pipeline later this year. But in short, we are excited about our next-gen platform and the potential therapeutic areas to which it could be applicable. Further development of these assets could help us expand beyond lipids and enter into new markets with significant unmet need, increase. Our addressable markets extend our product lifecycle and open the door to additional partnering opportunities as well as help us achieve long-term sustainable growth in summary, I'm excited for what I believe lies in-store for us, both now and in the future. And our path has never been clear or brighter. And with that, operator, we are now ready for Q&A to him.
Ladies and gentlemen, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced to withdraw your question, simply press star one one. Again, please stand by while we compile the Q&A roster.
Question and Answer Session
Operator
(Operator Instructions) Serge Belanger, Needham
Serge Belanger
Good morning.
Thanks for taking my questions. I guess for Sheldon, we're about 30 days away or so from the producer for the label expansion. Maybe just talk about the cadence of activities that would follow that label expansion, given that there's DCC. and -- what the plan is to do in terms of payers and formulary coverage?
Sheldon Koenig
Yes. Thank you, Serge, and good morning. And so yes, we are about 30 days away from our producer date. And just again, wanted to reiterate, I do not see any issues at all getting there. We've had some very positive interactions with the FDA. So again, feeling really confident about our label and the strategy that we've laid out regarding the label you heard about our five pillars that we mentioned in our prepared remarks as we get ready to launch this new label, which we've always said will be an inflection point for us as it relates to payers, we've been out talking to payers since the last ACC. March Saforis. I'm happy to say we've made great progress with the payers and we've seen some payers already making changes in anticipation of the new label.
I think what's also interesting in our prepared remarks, we mentioned that IsoRay just recently came out and made reference to next was that as being a cost effective therapy and essentially should be made available on all formularies. So that's something we'll also reimburse with payers. So we feel very confident about our payer strategy and the interactions that we have had with them.
To your point for ACC, again, we get the label, the new label end of March. Acc is around the April fifth timeframe. And we'll be using ACC as a way to really launch that new label and really make a big splash regarding the new label.
Eric Warren
And Serge, it's Eric, if I can add that to day one, our sales force will be ready to go. So April first, we have a full day of training to ensure that that team deploys rapidly. As Sheldon mentioned, we have the ACC. where we'll deploy the new campaign as well as we'll have speaker programs and scientific interaction. And then we'll transition to middle of April to have a launch meeting and start that digital as well as consumer program. So we've got a full slate of activities planned by day one. It's when we're beginning them.
Serge Belanger
Okay. So maybe just a follow-up in terms of gross to nets. How stable have they been through 2023? And maybe just talk what kind of impact you expect in the first quarter, whether they can improve once you have the label update and additional product volumes?
Ben Halladay
Yes, Serge, it's Ben. Thanks for the question. So I would say throughout 2023, we saw gross to net that were extremely in line with our expectations in regards to seasonality and where we think a healthy gross-to-net should be going into 2024. We expect that to be mostly the same as we'll see some incremental improvements in certain areas like distribution fees, that volume typically it helps bring down. But overall, we don't expect any major change or we should see the same sort of seasonality that we saw this year.
Serge Belanger
Thank you.
Operator
Tom Shrader with BTIG.
Tom Shrader
Good morning. Thank you for taking my call about the new label. So you've already had the maximum statin requirement or language dropped, has that had any effect on how payers treat the drug? And I guess what I'm I think what I'm hearing from you guys is that once you can market to see what the real driver is going to be the pull from physicians that they want the drug, which will be the big lever for getting payers to to make it available more easily. Is that correct or is it at the payer level that you really need to do your work? Thanks.
Eric Warren
Yes, great. Thanks, Tom. I'll let me start and then I'll ask BJ also comments to be made. So as you stated at the end of December, we saw that the FDA did what I would call harmonization of labels and every move and the maximum tolerated dose of statin. And they essentially acknowledged that we had outcomes very different from the label we'll be getting at the end of March, which will have the clear outcomes data.
Now with that said, there were some accounts. It actually acted as a catalyst for accounts to be prepared for the new label and some of them went forward and did make changes and removed that. I might step at it, for instance, but to your point, and one of the reasons why we've always said the new label would be a catalyst flash inflection point. Keep in mind, we're the only drug besides statins that studied not only secondary prevention but primary prevention. That's a big differentiation from drugs like Adomite and PCSK9 and keep in mind also in part of our strategy for our label is that you can use that so that on its own or you can use it with statins, so a doctor has choices now. And again, for those primary prevention patients, it's extremely important.
Now we've talked to payers about this. As mentioned in the last question, they're very receptive to what our new label will look like. We've talked to them. Of course, we won't know what our final label is until we get it. But we've talked to them of what it could look like and what we would need for them to do to change UM criteria. And for the most part, they've been very agreeable. And that will really then lessen the barrier of physicians being able to get the drug. That's what the label does. It makes it easier for physicians to get this drug on label right now is very narrow and very restrictive. As we mentioned in our prepared remarks, the population goes from 10 million to 30 million plus patients.
JoAnne Foody
I did say I com improving payer coverage, certainly matters as a priority. And we've been streamlining our consistency in utilization management. We actually have had UM criteria improve just in CVOT presentations, the interim label with over 16 claims both regionally and nationally, we are well poised for the new label, and we're very excited and those discussions have been continuing since last year's ACC to current day. And all the payers are anticipating the new label. So we feel very confident in that regard.
Tom Shrader
Okay. Thank you.
Operator
Jason Zemansky from Bank of America.
Jason Zemansky
Good morning. Thanks for taking our questions and congrats on the quarter. Two, if I may, please. I was hoping first, you could provide some color on the specific impact of FDA's label revision in December. I appreciate the holidays were right there, but was there any lift or acceleration either in interest or sales at that point with the loosening of restrictions?
Eric Warren
Hey, Jason, it's Eric. So we did drive that 8% growth, which is relatively consistent to prior quarters with the exception of second quarter. But Tim, as you know, that change that we saw we moved the maximally tolerated at requirement, but it still kept statins and a full payer changes didn't happen with regards to that removal. So yes, I would say it it kept us growing on the cadence that we were growing, but it didn't have a dramatic inflection like we anticipate when we're going to have the updated label in April first. So as Sheldon stated, not only is it a quantity of patient change going from 10 to 30, potentially 70, but it's a quality incorporating that primary prevention and fully removing VISTA and requirements.
Sheldon Koenig
And Jason, I would add that, yes, the thing about the new label that we'll have at the end of March is it will be the first time that our representatives, our medical liaisons, et cetera, can actually speak to clear outcomes data. So the growth that Eric spoke to and the growth that we've demonstrated through 2023 has always been on the what I would say, again, the very restrictive label that we had. So and we never thought of and we tried to actually take time with folks to explain the label change from December do not confuse that with what the label change will be at the end of March because that's what really opens the door for us as it relates to new patients and really be able to maximize the value of our products.
Jason Zemansky
Got it. And then so obviously, the NCE. one date passed last week. So generic companies can technically file for ANDAs for generic versions of Nextra tall. Next lose that wanted to ask, have you received any Paragraph four notifications from generic manufacturers.
Sheldon Koenig
We are aware of the data you mentioned, and it's something that we've been expecting. But no, we have not received anything today.
Operator
Yes, Thank you our next question coming from the line of Nelson with JPM Chase. Your line is open.
Yes, hey, guys. This is Nelson on for Jessica Fye And congratulations on a good quarter? And can you talk about how the shift in OUS manufacturing to GSCE., like how long that shift will take? And could you maybe see impact from that in 2024? And also, you mentioned there's a update of guidelines that could be on the horizon. I think how soon do you expect to see that potentially happening and then for OpEx in 4Q, the R&D guideline, is that a it's like is that as low as the company could go? Or is there some further development cost for the pipeline included in there?
Sheldon Koenig
Thank you. Ben, do you want to start with?
Ben Halladay
Yes. So I'll answer the manufacturing the OpEx question. So on the manufacturing transition to DSC tech transfer, which typically takes anywhere 16 to 18 months. We've been in discussions with them about the timeframe and moving that along as quickly as possible. I think it's in both parties' interests and both parties are very excited to get it done.
Yes. But that said, it will take time. We're working through the specifics of the plan, but there is a possibility we'll start seeing some of the working capital benefits towards the end of the year. And I wouldn't expect any of the gross margin savings to happen until next year when we're further along in the tech transfer, though.
And then on the OpEx guidance for R&D as we do, that guidance does include the preclinical pipeline spend. And so that's all inclusive, but I will say we have sort of meaningfully manage that OpEx down and work pretty pretty lean at this point.
Eric Warren
And I would just go to further add that we actually were in Munich about two weeks ago, we met with their manufacturing folks to do a kickoff of the tech transfer. It was a really good meeting and were off to a really good start with their team and working together to get this done related to guidelines.
And again, we have no impact on guidelines where somebody at the mercy of the folks that write the guidelines. There was some thought that guidelines would have come out in 2023. There's a potential maybe it could be 2024.
I do think once our new label comes out, there will be consensus statements, et cetera. But as it relates to when the actual new guidelines come out, we'll have to wait and see. But as you've probably have seen, there's been a lot of literature, a lot of things being both done, not only in the United States but in Europe as it relates to the use of bempedoic acid and where to use bempedoic acid, it's been very favorable. As a matter fact, in Germany, they actually last year issued up through their eight K authorities that you cannot use the PCSK9 until you've actually used that. But so I guess that first. So And stay tuned as we get more updates on US guidelines, et cetera, we will definitely update you on that.
Thank you.
Operator
Thank you. I'm showing no further questions in the queue at this time. I will now turn the call back over to Mr. Sheldon Koenig for any closing remarks.
Sheldon Koenig
Thank you so much.
Well, thank you, everybody. We really appreciate you taking the time and interest in Esperion Therapeutics. Again, I just want to remind everyone that we have a large catalyst coming in essentially less than a month with our new label. We had a very strong quarter, and that quarter is really going to and has created strong momentum as we enter into the first quarter of 2024. And with that said, we also have a steady stream of catalysts for our long-term continued growth. So thank you again and talk to you soon. Take care.
Operator
Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.
